EP0613667A1 - Implant fémoral de genou en matière plastique - Google Patents

Implant fémoral de genou en matière plastique Download PDF

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Publication number
EP0613667A1
EP0613667A1 EP94301438A EP94301438A EP0613667A1 EP 0613667 A1 EP0613667 A1 EP 0613667A1 EP 94301438 A EP94301438 A EP 94301438A EP 94301438 A EP94301438 A EP 94301438A EP 0613667 A1 EP0613667 A1 EP 0613667A1
Authority
EP
European Patent Office
Prior art keywords
component
polymer
total knee
femoral component
knee prosthesis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP94301438A
Other languages
German (de)
English (en)
Inventor
James A. Davidson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Inc
Original Assignee
Smith and Nephew Richards Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew Richards Inc filed Critical Smith and Nephew Richards Inc
Publication of EP0613667A1 publication Critical patent/EP0613667A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3877—Patellae or trochleae

Definitions

  • the present invention relates to surgical prosthetic devices and more particularly to an improved orthopedic knee implant that includes a polymeric femoral component, preferably of an ultra high molecular weight polymeric material that articulates against metallic (or ceramic or ceramic coated metal) patella and tibia components.
  • UHMWPE wear debris results from relatively rapid (compared to the tibial surface) wear of the UHMWPE patella surface. If the patella has a metal backing, this backing can eventually wear against the metal femoral surface following excessive polyethylene wear, and further aggravate the wear process and accelerate the adverse consequences via production of metal and UHMWPE debris.
  • Tibial wear of the UHMWPE has also been observed. Thinner UHMWPE surfaces on the tibia may allow eventual wear through to the underlying metal. Thicker tibial UHMWPE surfaces are desired but at the expense of excessive resection of the bone (tibia) during surgery.
  • the benefit of ceramic-UHMWPE wear combinations in the total hip joint and in laboratory tests have shown this wear combination to reduce friction and UHMWPE wear. Knee simulator tests in Japan have shown this to also be the case for monolithic ceramic knee femoral components articulating against UHMWPE.
  • both tibial and patella wear of the UHMWPE material occurs against the polished metal femoral surface.
  • the UHMWPE which undergoes wear in a constant area, such as the domed patella surface, or in a relatively constant area such as in the tibial surface. That is, the wear of the UHMWPE is not minimized because a particular region(s) of the UHMWPE remains in contact with the mating metal surface during relative motion (sliding distance) of the metal surface;
  • the wear factor K, of UHMWPE articulation against polished metal implant surfaces is the volume (mm3) of UHMWPE per unit stress and sliding distance.
  • U.S. Patent 3,688,316 which describes a prosthetic knee joint in which the femoral component has a polymeric bearing surface and the tibial portion is made from metal.
  • the prosthetic knee joint is formed of a polymeric bearing member, with an upstanding shank received in the femoral shaft, and a metallic rocking member inserted into the tibia.
  • the rocking member having a stem with a disc below the bearing member abutting the tibia, is pivotally supported with the aid of a transverse pin in the bearing member which is partly out away at the rear to permit a relative swinging of the two members over an arc of about 120°.
  • the present invention does not describe such a constrained hinge-type knee and which does not consider critical wear issues associated with current total knee designs in which each of the three knee components is replaced with artificial materials.
  • U.S. patent 4,034,418 describes a prosthesis in which the femoral component members are formed from a hard plastic material and the tibial portion has a highly polished metal upper surface.
  • the femoral component is in two pieces and not bridged.
  • the artificial knee joint of the '418 patent is for surgical implantation into a knee and comprises at least one femoral component of hard plastic material and at least one tibial member having a highly polished metal upper surface.
  • Each femoral member is received in a groove cut in the condyle of the femur, and its rear end face, constituting the inferior surface of the femoral member bears against the upper surface of the tibial member.
  • the inferior surface is arcuate polycentered in the sagittal plane and arcuate in the coronal plane.
  • the superior surface of the femoral member has three different planar portions angularly disposed to one another, for load bearing purposes and three different angles of flexion of the knee.
  • the femoral component is not bridged nor does it describe a total knee prosthesis in which the component replaces bone surface on the more wear-critical anterior portion of the knee femoral region.
  • this patent does not describe a total knee in which the patella is replaced to articulate against the anterior portion of the femur as described in the present invention, and which is a critical wear region as described earlier.
  • U.S. patents 4,596,734 and 4,923,550 (both assigned to B.F. Goodrich) relate to forming a composite of a metal support, an elastomer and a hard wearing surface formed from ultra-high molecular weight polyethylene.
  • U.S. patents 3,868,730, 4,268,920, and 4,355,429 relate to knee prostheses in which the tibial tray component holds a bearing surface formed from high molecular weight either metal or ceramics. This is in contrast to the present invention in which the knee femoral is described as made of a polymer surface (as opposed to metal or ceramic).
  • a more recent patent (U.S. No. 5,021,061) issued to Wevers and Rudan describes a polymer knee femoral insert component, but in which the femoral component portion articulating against the tibia (polyethylene) is metal.
  • the polyethylene insert is fixed to the anterior region of the two-component knee femoral for articulation against the metal patella.
  • the present invention describes a non-modular knee femoral of a suitable polymer bearing material to minimize wear of both the patella and tibial components, versus just the patella component as described in the Wevers and Rudan patent.
  • a cemented polyethylene femoral component was manufactured several years ago.
  • the anterior groove on the femoral component was a deep notch shape and not the shape of the natural femur in the region.
  • this device was thin (less than about 6mm) and simply cemented to the femur without any metal backing.
  • the present invention describes a more naturally designed femoral and patella geometry, similar to that of the original, intact knee, and which is popular in design for the majority of total knee systems in the market today.
  • the minimum polymer bearing thickness is greater than about eight millimeters (8mm) to assure proper rigidity and support, and to minimize contact stress in the polymer femoral component and thus minimize polymer wear.
  • the wear volume will be less because the location of peak contact area (peak stress) of the UHMWPE (femoral surface) will vary during articulation. Therefore, the relative travel distance between the peak stress UHMWPE area and the harder counter bearing surface will be reduced.
  • the particular high-stressed dome tip is under constant load as it travels roughly half an inch (under load) against a cobalt alloy femoral surface.
  • the patella button is metal or ceramic, and the femoral component is polyethylene, then the peak stress does not stay in the same UHMWPE location (now the femoral) during the same sequence of motion. Therefore the damage and wear of the UHMWPE for a given activity is spread out and reduced.
  • Another advantage of using a polymer femoral component is that less resection of the tibia will be required during surgery. Better bone stock and support can thus be maintained for the tibial surface. Likewise, the patella button will require less resection. Moreover, a polymeric femoral component will better transfer load to the underlying bone compared to stiff metal or ceramic femorals components.
  • polymer-polymer wear couples do not necessarily provide both low friction and wear during articulation in lubricating mediums. Wear and friction of appropriate metal-polymer and ceramic-polymer wear couples can produce lower levels of friction and wear, and is thus the preferred combination in total knee (and hip) arthroplasty. Further, environmental degradation resistance must be sufficient, particularly against attack by lipids and oxidants.
  • the present invention provides a polymer (such as UHMWPE) knee femoral component articulating against a polished metal (i.e., cobalt alloy) or preferably ceramic (i.e., alumina, zirconia, nitrides, or borides) patella and tibial components in a total knee implant.
  • the polymer femoral material can be polymers other than UHMWPE or can also be any suitable polymer blend, or fiber-reinforced or particle-reinforced polymer, or layered polymers with appropriate strength, creep, wear resistance, and friction when articulated against metal or ceramic counter bearing surfaces of the patella and tibial component.
  • the polymer must be suitably resistant to environmental degradation (particularly by oxidation, fats, and lipids).
  • the polymer femoral component can be cemented directly to the femoral resections made during surgery or may incorporate the use of metal or other more rigid backing (full or partial) to enhance cement fixation and wear resistance of the polymer wear surface, or to allow for a surface texture or porous metal bead or mesh coating to be applied for bone ingrowth fixation.
  • the polymer femoral component can also have a porous polymer surface to allow for bone ingrowth or a porous metal mesh surface attached directly for bone ingrowth.
  • the mating patella and tibial components can be existing implant metals such as cobalt alloy, titanium alloy, or stainless steel with an appropriate polished surface for articulation against the polymer femoral component surface. Surface roughness (Ra) should be less than about 0.05 micron.
  • the patella and tibial components can also be made of other alloys such as those of zirconium, tantalum, and niobium, or these and existing metals with a protective, hard, inert, ceramic coating or other surface hardening treatment such as ion-implantation, internal oxidation, gas diffusion hardened, carbonization, nitriding, etc.
  • the tibial or patella components can be made of solid (monolithic) ceramic such as alumina, zirconia, or silicon carbide.
  • a total knee prosthesis comprising:
  • the preferred embodiment of the apparatus of the present invention provides a metal-backed UHMWPE or other appropriate low wear, high strength (and creep resistance) high degradation resistant, low friction polymer or polymer blend knee femoral component articulating against a polished cobalt alloy or ceramic (or ceramic coated metal) patella and tibial knee component.
  • the femoral component is made of metal or a metal alloy such as Co-Cr-Mo Alloy.
  • the tibial and patella components are made of plastic or polymer at least with respect to the portions subject to friction and wear.
  • Figure 1 illustrates a prior art total knee prosthesis 3 having a metallic tibial component 4 with a fixation component 5.
  • a polymer insert 6 (such as an ultra high molecular weight polyethylene) is secured on top of the metal tibial component 4.
  • a metallic femoral component 7 has an articulating surface portion that bears against a corresponding articulating surface portion of the polymer insert 6.
  • a polymeric patella component 8 also provides an articulating surface with the metallic femoral component 7.
  • the plastic patella component can have a metallic backing portion 9.
  • the total knee prosthesis 10 includes a tibial component 11 and a femoral component 12.
  • the tibial component 11 includes a tibial tray 13 and an optional fixation component 14 for improving surgical connection of the tibial component to the patient's tibia if needed.
  • the tibial component includes a flat underside portion 16 and an upper concave articulating surface 15.
  • the femoral component 12 provides a polymeric portion 17 and can optionally have a metallic or other rigid material as a backing member 18.
  • a porous coating or surface texture 19 can also be employed to provide a tissue ingrowth surface.
  • the metallic or rigid backing is defined by flat surfaces 20-24.
  • Curved surface 25 defines a convex or biconvex articulating surface that fits with the concave or biconcave articulating surface 15 of the tibial component and is contoured to essentially mimic the surface of the intact knee femoral surfaces.
  • Patella component 26 is also preferably metallic, such as of a cobalt alloy or ceramic or ceramic-coated metal.
  • the essentially hemispherical patella component 26 similarly can have a bone ingrowth surface 27.
  • the patella component can be all metal, ceramic, or ceramic coated metal.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
EP94301438A 1993-03-05 1994-03-01 Implant fémoral de genou en matière plastique Withdrawn EP0613667A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/027,000 US5358529A (en) 1993-03-05 1993-03-05 Plastic knee femoral implants
US27000 2001-12-18

Publications (1)

Publication Number Publication Date
EP0613667A1 true EP0613667A1 (fr) 1994-09-07

Family

ID=21835084

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94301438A Withdrawn EP0613667A1 (fr) 1993-03-05 1994-03-01 Implant fémoral de genou en matière plastique

Country Status (5)

Country Link
US (1) US5358529A (fr)
EP (1) EP0613667A1 (fr)
JP (1) JPH06296630A (fr)
AU (1) AU667001B2 (fr)
CA (1) CA2117039A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0685210A1 (fr) * 1994-05-13 1995-12-06 SMITH & NEPHEW RICHARDS FRANCE Implant trochléen pour prothèse fémoro-patellaire et son instrumentation de pose
DE19816984A1 (de) * 1998-04-17 1999-10-21 Ceramtec Ag Kniegelenkprothese mit verschleißarmer Bahnführung der patellaren Komponente
EP1437104A1 (fr) * 2003-01-07 2004-07-14 Ascension Orthopedics, Inc. Prothèse pour articulation carpo-métacarpienne
US7108720B2 (en) 2003-03-31 2006-09-19 Depuy Products, Inc. Reduced wear orthopaedic implant apparatus and method
US8834574B2 (en) 2010-12-07 2014-09-16 Zimmer, Inc. Prosthetic patella

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US5358529A (en) 1994-10-25
AU5755294A (en) 1994-09-08
AU667001B2 (en) 1996-02-29
CA2117039A1 (fr) 1994-09-06
JPH06296630A (ja) 1994-10-25

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